KR100825190B1 - A system for mapping the interior of bodily cavity of a patient, the device therof and the method thereof. - Google Patents

Abstract

The present invention is a system for mapping and imaging the interior of the cavity of a patient's body. According to the present invention, the position display means (63) in which the body can be variously positioned in the cavity; the position detection means (64) for receiving a signal from the position display means (63), and the position analysis means for analyzing the signal A processor that provides an output indication of the location of the means 63. The invention also includes first imaging means 65 located therein and generating a first image therein, and second imaging means 62 located therein and generating a second image therein. The second imaging means 62 may be located relative to the first imaging means and in an area where the first image represents the position of the second imaging means 62.

Mapping, map, image, intervertebral disc, nuclear

Description

A system for mapping the interior of bodily cavity of a patient, the device therof and the method approximately.

1 shows a number of transverse planes through the intervertebral disc of a patient;

2 shows a front view of a disc-spine connection of a patient;

3 shows a cross section of an annularizing device;

4 shows a cross section of the spinal dilator mechanism;

5 (a) to 5 (e) show the steps of replacing and annulting the intervertebral disc of the patient;

6 (a) to 6 (c) are cross sectional views of the insertion of a nucleus pulmonary replacement device using the delivery mechanism of the present invention;

7 shows an example of an apparatus for providing an internal map of the nuclear space of an intervertebral disc;

8 shows the use of the device of FIG. 7;

9 is a flowchart of the geometric measurement system of the nuclear space of the intervertebral disc.

The present invention provides a system, apparatus and method for mapping cavities within the body of a patient; The present invention relates to a method for implanting a nucleus pulposus replacement device, a delivery device for transplantation of a nucleus pulposus device, and a sealing mechanism for sealing a cavity of a patient's body.

The Human Intervertebral Disc (IVD) is a structure that contains a complex array of various connective tissues. The structure of the IVD is responsible for the effects of spinal column function. The degeneration of IVD is the result of aging and can begin as early as possible in the teenage years for men and in the twenties for women. Disc degeneration is an important pathogenesis of nucleus pulposus herniation, spinal stenosis and segmental spinal stability. Moreover, IVD degeneration is epidemiologically associated with significant etiology of lower back pain.

Over the years, several proposals and techniques have been made regarding the development of artificially inserted IVD expansion devices. Such devices include whole spinal column replacement and replacement of the nucleus only. Still other therapies include therapies such as dissolution and nucleotomy for degenerated discs. Artificial devices aim to repair or maintain the intact intervertebral segment and reduce further degeneration of neighboring spinal column.

Devices to replace the entire spinal column is a mechanical holding device, wherein the mechanical retainer comprises a is a spinal segmental (intersegmental) stability using the end plate is secured to the spinal column and elastic "nuclear" rubber neighborhood between the end plate Keep it. Another type of device includes a 'metal on metal' prosthesis that extends across neighboring vertebrae.

Nucleotide replacement devices involve nucleation or increase in nucleus in the case of IVD degeneration in a general annular structure. Such devices include prosthetic disc nuclei (eg, PDN ^{™ from} RayMedica, Minneapolis, MN) made of hyaluronic acid (hydroscopic gel) in a semipermeable membrane surrounded by a woven jacket. A pair of these devices are inserted per spinal column. Over time, absorption increases the water capacity of the device and consequently expands the volume of the device. Another such nucleolar replacement device is Aquarelle ^™ Hydrogel Disc Nucleus (Stryker Howmedica Osteonics, Rutherford, NJ). The device consists of a hydrogel disc nucleus, which is inserted into the intervertebral disc via an annular hole using an instrument, the hole being about one quarter of the cross-sectional area of the implant. Has a cross-sectional area of. The implant comprises polyvinyl alcohol and water, the water capacity of which is high at the intervertebral disc pressure found in the human lumbar spine. This property indicates that the implant has a relatively low coefficient of expansion, which allows the implant to coincide with the spinal distal plate of the adjacent spinal bone.

The present inventors have developed a system that can find defects and overcome disadvantages within the technical scope known in the art.

Any discussion contained in the paper, experiments, materials, devices, components or the like of the present invention is intended to be provided only in connection with the present invention.

Some or all of these materials should not be treated as prior art in forming the basis of known knowledge or prior art that existed before the filing date of each claim of this application in the technical field related to the present invention.

In the present specification, the meaning of the term 'comprises' or 'comprises', including 'comprises', and the like, means the described component, complete or step, or a group of components, completes, or steps. It should be understood to include a group, and not to exclude any other component, complete or step, or a group of components, completes, or steps.

Hereinafter, the present invention will be described in detail.

1 shows the annular wall 2 of the intervertebral disc 3 of the patient. The spinal column of the patient is indicated by reference numeral 1. The nucleus 10 of the intervertebral disc 3 is located in the annular wall 2.

2 shows the intervertebral disc 3 of a patient located between two adjacent spinal column 1 of the patient. The nucleus 10 of the inner spinal disc 3 is surrounded by the spinal column 1 and the annular wall 2.

3 is a cross section of an annularizing device 20 for annularizing the annular wall 2 of the intervertebral disc 3 of the patient. The localizer pin 21 is located in the center of the annularization device 20. Trocar member 22 surrounds the localizer pin 21 concentrically. The annular member 23 surrounds the trocar means 22 concentrically. The localizer pin 21, the trocar means 22 and the annular member 23 are slidably engaged with each other.

In a detailed example of the annularizing device, the localizer pin 21 is formed of a biocompatible material such as stainless steel and has a diameter of about 1.5 mm. The distal diameter of the trocar means 22 is about 1.55 mm so that the localizer pin 21 can slide into the trocar means 22. The outer diameter of the trocar means 22 is preferably about 3.5 mm.

The end of the trocar means 22 is serrated so that it can firmly engage the outer surface of the annular wall of the intervertebral disc of the patient without slipping. The annular member 23 also has a cutting edge at its end with an outer diameter of about 4.5 mm. The inner diameter of the annular member 23 is slightly larger than the outer diameter of the trocar to allow sliding engagement.

As shown in FIG. 4, the expansion device 30 may have an elongate delivery member 31 and an inflatable distraction member 32. Preferably, the inflatable expandable member 32 is an inflatable balloon inflatable by compressed fluid. Preferably, the fluid used is a bio-inert material comprising saline and physiological fluids. A plurality of radiopaque markers 33 are included on the outer surface of the expandable expansion member 32. The radiopaque marker 33 may be metal or may be a metal mixture.

5 (a) to 5 (e) show an example of use of the annular apparatus 20 of FIG. 3 and an example of using an intervertebral disc expansion mechanism. FIG. 5A shows how the annular device 20 of FIG. 2 engages the intervertebral disc 3 of the patient using a posterio-lateral surgery approach. Other approaches are also useful. The trocar means 22 and the annular member 23 engage with the outer surface of the annular wall 2 of the intervertebral disc 3. The localizer pin 21 is used to initially position the site where the intervertebral disc 3 will be annular. Once the localizer pin 21 is in position and the annular wall 2 is penetrated by the localizer pin 21, the trocar means 22 and the annular member 23 use the localizer pin 21. Guided to the outer surface of the annular wall 2, the trocar means 22 and the annularizing member 23 are positioned as shown in FIG.

Then, the annular member 23 is used to annular the annular wall 2 as shown in FIG. 5 (b). A cutting surface located at the distal end of the annular member 23 cuts the annular wall 2. By engaging the outer surface of the annular wall 2, the trocar means 22 supports the annularizing member 23 while the annular wall 2 is being cut.

Then, a surgical cannula 24 having an outer diameter slightly larger than the outer diameter of the annular member 23 couples to the outer surface of the annular wall 2 as shown in FIG. 5 (b). ) Is used to guide the procedure insertion tube 24 to a position that engages the outer surface of the annular wall 2. The surgical insertion tube 24 may have engagement means for engaging the outer surface of the annular wall 2. Engagement means include pins, barbs or spikes. The localizer pin 21 and trocar means 22 are separated from the patient before and after the surgical insertion tube 24 engages the outer surface of the annular wall 2. Once the surgical insertion tube 24 is engaged, the annular device can be separated from the patient through the surgical insertion tube 24. The stabilization device 25 may be used outside of the patient to stabilize the surgical insertion tube 24 (see FIG. 5 (c)).

The ablation device 40 is then inserted into the nucleus 10 of the intervertebral disc 3 through the surgical insertion tube as shown in FIG. 5 (c). The ablation apparatus 40 is used to ablate the nucleus 10 of the intervertebral disc 3. The ablation device 40 may be, for example, a mechanical ablation device or a radio-frequency tissue ablation device. Once the ablation is complete, the excised nucleus 10 can be cleaned using saline or physiological liquid. A radiopaque dye, for example a dilute barium sulfate solution, can be injected into the nucleus 10, to measure the binding of the trocar means 22 and to determine whether a leak has occurred into the spinal canal of the patient. Can be scanned using radiographic techniques. In addition, arthroscopic techniques may be applied through the surgical insertion tube 24 for examination of the nucleus 10.

The intervertevral space between the spinal column 1 of the patient expands after ablation of the nucleus 10. As shown in FIG. 4, the extension may be a pull and / or an internal extension using an extension. The ablation device 40 is separated from the patient through the surgical insertion tube 24, and the expansion member 32 of the expansion device is external to the patient through the surgical insertion tube 24, as shown in FIG. 5 (c). It is inserted into the resected nucleus through the surgical insertion tube 24 together with the delivery member 31 extending to.

Pressurized fluid, for example saline, is injected into the expansion means 31 via the delivery member 32. And while the expansion of the spinal column 1 adjacent to the intervertebral disc 3 takes place. As shown in FIG . 5 (e) while the expansion member is inflated, the patient can be imaged using radiographic techniques to measure the geometric parameters of the nucleus 10 of the intervertebral disc 3.

Figure 6 (a) shows the implantation of a nucleus pulposus replacement device in the nucleus 10 of a patient's intervertebral disc 3 according to the present invention. Implantation of a nucleolar replacement device may be accomplished by steps according to the process described in FIG. 5.

The delivery mechanism 41 is inserted into the surgical insertion tube 24 and into the nucleus 10 of the intervertebral disc 3. The material 50 is then injected into the nucleus 10 of the intervertebral disc 3 via the delivery mechanism 41 while the material 50 in which the nucleus nucleus replacement mechanism is formed is in a first state suitable for injection. Material 50 may substantially coincide with the interior of nucleus 10.
The material 50 is mechanical and visco-elastic suitable for nucleus replacement. An example of such a material 50 is a silicon based material. Preferably, the material preferably has a self-curing property, and the property of the material changes to a second state having mechanical properties suitable for nucleation of the nucleus by this self-curing property.

When the material 50 is cured, the disassembly means 42 of the delivery mechanism 41 causes the delivery mechanism 41 to be dismantled from the self-cured material 50 and separated from the procedure insertion tube 24. To be. The nucleus nucleus replacement mechanism remains inside the nucleus 10, which substantially coincides with and is constrained by the nucleus of the nucleus of the cured material 50.

6 (b) shows another example of implantation of a nucleus pulposus replacement device, which further comprises an outer membrane 43. During implantation of the nucleus nucleus replacement mechanism, the membrane 43 is fluidly attached to the delivery mechanism 41 at the dismantling means. The delivery mechanism 41 is inserted into the surgical insertion tube 24 and the membrane 43 is located in the nucleus 10 of the intervertebral disc 3. From the nucleus nucleus replacement mechanism, material 50 is transferred in the same manner as described in FIG. Upon injection and depending on the degree of pressure, the membrane 43 substantially coincides with the inner surface of the nucleus 10. When cured, the delivery mechanism 41 is separated from the material 50 and the membrane 43 and removed from the surgical insertion tube 24.

6 (c) shows an example of the removal of the delivery mechanism 41 following the curing of the material 50. In this example, the delivery mechanism is disassembled from the substance 50 and the membrane 43 by rotating the delivery mechanism 41 in the procedure insertion tube 24 to separate it from the procedure insertion tube 24.

7 shows an example of a device 60 that can be used to generate an internal map of the nuclear space of the intervertebral disc 3 of a patient. The device 60 includes a transmitter 63 and a receiver 64. The transmitter 63 is located at the end of the flexible portion 61 of the device 60. The position and orientation of the flexible portion 61 is controlled by the surgeon outside the body of the patient so that the position of the transmitter 63 varies with the position of the receiver. The transmitter 63 transmits a signal to the receiver 64 to determine the position of the transmitter. A suitable example of a transmission mode is infrared. In this example, the transmitter 63 lies in line-of-sight directly from the receiver 64. In addition, the reflector means may be located adjacent to the receiver and located at the end of the flexible part 61 of the transmitter, or may consist of a receiver in the shape of a transceiver. The device 60 further comprises an optical camera 62 and a second optical camera 65 located at the distal end of the flexible portion 61. The support member 69 maintains the optical camera 62 and the second optical camera 65 at a constant distance from each other so that the image provided by the second optical camera 65 indicates the position of the optical camera 62. Optical camera 62 and / or second optical camera 65 may be a video camera. The digital image acquired by the second optical camera 65 may be provided to track the position of the optical camera 62 by imaging analysis techniques. The second optical camera 65 may be an arthroscopy and the flexible portion 61 may be part of the arthroscopy. Light source 67 may be included as illumination means for imaging by the optical camera in the visible spectrum.

The ablation device 66 may also be located at the end of the flexible portion 61. Examples of suitable ablation devices include radio frequency type probes. An example of another suitable ablation device is a plasma emitting device.

8 shows an example of use of the device of FIG. 7. The device may be used to ablate the nucleus of the intervertebral disc of the patient and to map the outer edge of the nucleus 10 space. The device 60 is inserted at least partially through the surgical insertion tube 24 into the space of the nucleus 10 of the intervertebral disc of the patient. Examples of suitable surgical approaches include the posterior-lateral approach and the anterior approach.

The optical camera 62 is located at the end of the flexible portion 61. The ablation device 66 is used to ablate the interior of the space of the nucleus 10. The portion of the nuclear space in which the ablation is made can be imaged by the optical camera 62 and is visible to the surgeon during the procedure. The optical camera 65 enables global imaging of the distal end of the device 60 and ensures that visual monitoring of the ablation device 66 during surgery is assured that the ablation device 66 is used correctly.

The transmitter 63 located at the distal end of the flexible portion 61 outputs a signal indicating the position of the distal end of the device 60 relative to the receiver 64 and thereby the position within the nucleus 10. In the example of the above device, although the receiver 64 can be located outside of the patient's body, the receiver 64 is located within the nucleus 10. Examples of suitable modes of signal transmission in this example are infrared transmission and high frequency transmission.

The relative position of the transmitter 63 relative to the receiver 64 can be manipulated by an external processor to allow an internal map of the nucleus 10 to be made. The transmission of the signal from the transmitter 63 may be continuous or intermittent or manipulated by the user. The user may position the distal end of the device 60 inside the nucleus 10 with the aid of the optical camera 65 and an externally operated transmitter 63 to determine the coordinates or location of the transmitter 63. Multiple transmissions at various locations along the periphery of the nucleus 10 allow for the development of maps or visual representations representing the volume and geometrical shape of the nucleus 10.

The map or visual representation of the nucleus 10 output by the processor is practical and preliminary from various imaging techniques such as X-rays, computer aided tomography, ultrasound and magnetic resonance imaging. It can be compared with images of nuclei obtained or simultaneously acquired. In addition, the image can be superimposed with a map of the nucleus to allow for determining the extent of ablation or to monitor the position of the device 10.

9 is a representative flow chart of a system using the date of device 60. The system shown in FIG. 9 provides visual monitoring of the ablation apparatus 66 by the second optical camera 65 and the analysis of the site and tissue of the ablation nucleus that is ablation by the optical camera 62. Visual monitoring may be provided by a first monitor for display of an image from the optical camera 62 and a second monitor for display of an image from the second optical camera 65. Alternatively, a single monitor can display both the image by the optical camera 62 and the image of the second optical camera 65.

The image provided by the processor may be displayed in real time in real time with the internal map provided by the processor on the comparison display, as described with reference to FIG. 8. Once the tissue is excised by the ablation device, the map can be updated and compared with the actual image. The update of the image allows the user to determine a new actual image of the cavity mapped to the user and allows the user to know where the ablation device is located in the cavity by compositing the updated image with a given actual image. Make sure The comparative display may be integrated with a display representing an image from the optical camera 62 and an image provided from the second optical camera 65. The receiver can be located inside or outside the cavity of the body. The cavity of any body of the patient may be mapped in this manner, including the internal nuclear space of the intervertebral disc of the patient.

Systems incorporating such features allow the surgeon to assess the internal space of the patient's intervertebral disc and provide positional information that the surgical instrument is located inside the intervertebral disc. Furthermore, the data representation of the internal geometry of the intervertebral disc of the patient provided by the system allows the selection of an appropriately sized implant for nuclear pulposus replacement.

EXAMPLE

As a first feature, the present invention provides a system for imaging the interior of a cavity of a patient's body (hereinafter referred to as "imaging").

First imaging means that can be disposed inside a cavity of the body and capable of producing a first image; And
And second imaging means that can be disposed within at least the cavity of the body and capable of producing a second image.

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The second imaging means is movable relative to the first imaging means and can be arranged at a position where the first image indicates the position of the second imaging means.

In a specific embodiment of the first feature, the system further comprises display means for displaying the first and second images. Preferably said display means comprises a first monitor for said first image and at least a second monitor for said second image. The display means alternatively comprises a monitor for displaying the first image and at least the second image. Preferably the system further comprises luminaires for illuminating the cavity.

In another embodiment of the first aspect, the system comprises tissue ablation means for ablation of tissue in the cavity of the body, the ablation means being relatively movable relative to the first imaging means. Preferably the first image indicates the direction and location of the tissue resection means. More preferably the tissue resection means is located adjacent to the second imaging means, and the second image indicates the tissue to be resected.

In another embodiment of the first aspect, the tissue ablation means is preferably a radio frequency ablation device or a plasma discharge device.

In another embodiment of the first aspect, the first imaging means is a camera, more preferably the camera is a video camera. Preferably said second imaging means is a camera, more preferably said camera is a video camera. In each case the camera may be an analog or digital camera. The second imaging means is an arthroscope. Preferably the arthroscopy includes a flexible extension, over which the camera is positioned, the camera being adjusted to be inserted into the cavity of the body, the flexible extension being adjacent to the inlet of the arthroscopy. The perimeter of the body's cavity can be seen and accessed. More preferably, the first imaging means and the second imaging means are located above the support member and maintain a relatively constant distance from each other.

Preferably the support member can be inserted at least partially into the cavity of the body. Preferably the first imaging means is arthroscopy.

In another embodiment of the first aspect, the system

Position display means capable of various positions in the cavity of the body;

Position detecting means for receiving a signal from said position display means;

Process means for analyzing the signal and providing an output indicating the relative position of the position indicating means relative to the position detecting means.

Preferably the signal is selected from the group comprising infrared, ultrasonic, magnetic waves, radiofrequency, X-ray and visual image signals.

Preferably the position indicating means is a transmitter means and the position detecting means is a receiver means. Alternatively the position indicating means is a reflecting means and the position detecting means is a transceiver means and further the signal is first transmitted from the transceiver means and reflected back to the transceiver means by the reflecting means.

Preferably the output of the process means is used to create an image of the cavity of the body. More preferably the system comprises a comparator which visually compares the image with a real image of the cavity of the body. Preferably the comparator allows to determine the direction of the second imaging means in the cavity. The transmitter means may be located at or near the position of the second imaging means.

Preferably, the real image is obtained using an imaging technique selected from the group including X-ray imaging, magnetic resonance imaging and computed tomography. Preferably the actual image is obtained prior to the mapping of the cavities of the body. Alternatively the actual image is obtained during the mapping of the cavities of the body. Preferably the actual image is continuously updated during the mapping of the cavities of the body. Preferably the receiver means can be located outside the cavity of the body. Alternatively the receiver means may be located inside the cavity of the body.

In another embodiment of the feature of the invention, the cavity of the body is the nuclear space of the intervertebral disc.

In another embodiment of the feature of the invention, the cavity of the body is a cavity of a joint.

As a second aspect, the present invention is a system for mapping the interior of the cavity of the patient's body, the system,

Position display means that can be located in a variety of cavities of the body;

Position detecting means for receiving a signal from the position indicating means;

Process means for analyzing the signal and providing an output indicating the relative position of the position indicating means relative to the position detecting means.

In an embodiment of the second aspect, preferably the position indicating means is a transmitter means and the position detecting means is a receiver means. Alternatively, the position indicating means is a reflector means, the position detecting means is a transceiver means, furthermore the signal is first transmitted from the transceiver means and then returned to the transceiver means by the reflecting means. Reflected.

Preferably the signal is selected from the group comprising infrared, ultrasonic, magnetic, radio-frequency, X-ray and visual image signals.

In another embodiment of the second feature, preferably the output of the process means is used to create a map of the cavity of the body. Preferably the system further comprises a comparator that visually compares the map with the actual image of the cavity of the body. Preferably, the actual image is obtained using an imaging technique selected from the group including X-ray imaging, magnetic resonance imaging and computed tomography. Preferably the actual image is obtained prior to the mapping of the cavities of the body. Alternatively the actual image is obtained during the mapping of the cavities of the body.

In another embodiment of the second aspect, the system further comprises tissue ablation means for ablation of tissue within the cavity of the body, the ablation means being relatively movable relative to the position detection means, Disposed adjacent to the position indicating means to indicate the position of the tissue ablation means. Preferably the tissue ablation means is a radio frequency ablation device. Alternatively, the tissue ablation means is a plasma discharge device. Preferably the actual image is continuously updated during the mapping of the cavities of the body.

In another embodiment of the second aspect, the position detecting means may be located outside the cavity of the body. Alternatively, the position detection means may be located inside the cavity of the body.

In a second further embodiment of the feature, the system further including observation means for imaging the interior of the cavity (cavity) of a patient's body, wherein the observation means;

First imaging means that can be disposed inside a cavity of the body and capable of producing a first image; And

Second imaging means capable of at least disposed inside a cavity of the body and capable of producing a second image; Including;

Wherein the second imaging means is movable relative to the first imaging means, and the first image may be disposed at a position representing the position of the second imaging means.

In another embodiment of the second aspect, the cavity of the body is the nuclear space of the intervertebral disc.

In another embodiment of the second aspect, the cavity of the body is a cavity of the joint.

A third aspect of the invention is a method of imaging the interior of a cavity of a patient's body, wherein the imaging method is

Generating a first image in the cavity of the body, produced by a first imaging means that can be located within the cavity of the body;

Generating at least a second image in the cavity of the body, produced by a second imaging means that can be located within the cavity of the body; And

Positioning the first imaging means at a location where the first image indicates the location of the second imaging means;

It includes.

In an embodiment of the third aspect, the imaging method comprises using the system of the first feature and related embodiments.

According to a fourth aspect, the present invention is a method for mapping the inside of a cavity of a patient's body, and the mapping method is

Introducing a positioning means into the cavity of the body which can be placed in various positions within the cavity of the body;

Positioning the position detecting means for receiving a signal from the position indicating means;

Analyzing the signal and providing an output indicating the relative position of the position indicating means relative to the position detecting means;

It includes.

Preferably the signal is selected from the group comprising infrared, ultrasonic, magnetic, radio-frequency, X-ray and visual image signals.

In an embodiment of the fourth aspect, the signal analysis step may be performed by a processor means.

In a fourth embodiment, the position indicating means is a transmitter means and the position detecting means is a receiver means. Alternatively, the position indicating means is a reflecting means, the position detecting means is a transceiver means, furthermore the signal is first transmitted from the transceiver means and then reflected back to the transceiver means by the reflecting means.

In another embodiment of the fourth aspect, the mapping method further comprises using the output of the process means to create an image of the cavity of the body. Advantageously, said mapping method further comprises the step of presenting a joint image of said body on a display map. More preferably the mapping method further comprises comparing the image with the actual image of the cavity of the body.

Preferably, the real image is obtained using an imaging technique selected from the group including X-ray imaging, magnetic resonance imaging and computed tomography. Preferably comparing the actual image and the map (map),

Determining an actual position of the position detecting means with respect to the cavity of the body; And

Superimposing the actual position of the position detection means on the display means together with the actual image of the cavity of the body;

It includes.

In yet another embodiment of the fourth aspect, the method further comprises: cutting at least a portion of the cavity of the body using ablation means; And updating the map during the ablation.

In another embodiment of the fourth feature, the method comprises the use of a system according to the third feature and a related embodiment.

In a fifth aspect of the invention, the invention provides an apparatus for imaging the interior of a cavity of a patient's body;

A support member, which may be located partially inside the cavity of the body;

First imaging means capable of being coupled to the support member to produce a first image therein; And

A second imaging means capable of combining with the support member to produce at least a second image therein;

The second imaging means may be located relative to the first imaging means and at a location where the first imaging means has indicated the position of the second imaging means.

In an embodiment of the fifth aspect, the imaging device further comprises tissue ablation means for ablation of tissue within the cavity of the body, the ablation means being coupled to the support member, the ablation means being coupled to the first imaging means. Relatively movable relative to Preferably, the tissue resection means is located adjacent to the second imaging means and the first image indicates the position and orientation of the tissue resection means.

In another embodiment of the fifth aspect, the imaging device comprises an embodiment of the first aspect.

As a sixth aspect, the present invention provides an apparatus for mapping the interior of a cavity of a patient's body, the apparatus comprising:

A support member at least partially positioned in the cavity of the body;

Position indicating means that can be coupled to the support member, can be located in a variety of within the cavity of the body;

Position detecting means for receiving a signal from said position display means; And

Process means for analyzing the signal and providing an output indicating the relative position of the position indicating means relative to the position detecting means.

Preferably the signal is selected from the group comprising infrared, ultrasonic, magnetic, radio-frequency, X-ray and visual shape signals.

In a sixth embodiment, the position detecting means may function together with the support member and be located within the cavity of the body.

In another sixth embodiment, the position indicating means is a transmitter means and the position detecting means is a receiver means. Alternatively, the position indicating means is a reflecting means and the position detecting means is a transceiver means and further the signal is first transmitted from the transceiver means and reflected back to the transceiver means by the reflecting means.

In another embodiment of the sixth aspect, the apparatus includes tissue ablation means for ablation of tissue within the cavity of the body, the ablation means being coupled to the support member and being relatively movable relative to the position detection means. Preferably, the tissue ablation means is located adjacent to the position indicating means.

In a seventh aspect, the present invention provides a nucleus replacement device comprising a non-constrained body of material that can be inserted into and positioned in an intervertebral disc annulus of a patient; The body of material is inserted into the intervertebral disc ring and then changes from the first state to at least the second state, in which the body of the material is constrained in the intervertebral disc ring.

In one embodiment of the seventh feature, the body of material engages with and borders the boundary of the intervertebral disc ring.

In another embodiment of the seventh aspect, the body of the nucleophile replacement device is made of a material having mechanical and visco-elastic properties, which is suitable for structural support and for buffering the load in the spinal column of the patient.

In yet another embodiment of the seventh aspect, the nucleophile replacement device further comprises a non load-bearing membrane disposed on the outer edge of the material body, wherein the membrane is impermeable to the material body. impermeable).

Preferably, the material body is made of a material based on silicon. The material can be shaped to change from the first state to at least the second state and to cure after implantation within the intervertebral disc ring of the patient. In one embodiment, the body of material cures subsequent implantation.

The nucleolar replacement device may be used to deliver bio-active material to the intervertebral disc rings of the patient. The bioactive material may be a material for inducing cell growth and / or cell regeneration.

In another embodiment of the seventh aspect, the nucleolar replacement device may be used as a drug delivery means for active and / or prophylactic treatment in a transplant site.

In another embodiment of the seventh aspect, the nucleolar replacement device may comprise radioactive material and / or radiopaque label for monitoring by X-ray after surgery.

As an eighth aspect, the present invention provides a method for replacing the nucleus pulposus of an intervertebral disc of a patient, using the apparatus of the first aspect, the method comprising;

(i) resecting the nucleus space of the intervertebral disc of the patient by ablation in the intervertebral disc;

(ii) expanding the intervertebral disc;

(iii) inserting the body of material into the ablation nucleus space; And

(iv) deforming the material body from the first state to the at least one second state so as to cure within the intervertebral disc ring.

It includes.

In one embodiment of the eighth feature, ablation through the intervertebral disc loop is made by accessing the intervertebral disc through a surgical approach that includes a posterior-lateral approach and / or an anterior approach.

In another embodiment of the eighth feature, the intervertebral disc can be expanded using expansion means and / or conventional contractions. Preferably the intervertebral disc is expanded by means of expansion that enters the resected nucleus through the ablation site in the intervertebral disc ring.

In yet another embodiment of the eighth aspect, the expansion means used in the intervertebral disc expansion step is a balloon device. The instrument is preferably inflated by fluid to expand the intervertebral disc. The fluid used to extend the instrument is preferably biocompatible. Examples of suitable fluids are saline, phosphate buffered saline (PBS) and sterile water. Another example includes the material of the nucleus nucleus replacement device according to the seventh aspect.

In another embodiment of the eighth aspect, the method of replacing the nucleus pulposus may comprise another step between steps (i) and (ii), wherein the nuclear space may contain debris, bone fragments and / or loosened cell fragments. It is washed to remove the back.

In another embodiment of the eighth feature, the instrument expanding means may comprise radiopaque markers that can be viewed by imaging means such as X-rays and pre-screen the placement of the instrument. Can be.

In another embodiment of the eighth feature, after the intervertebral disc is expanded by the instrument expanding means, the instrument is preferably removed from the nuclear space. Then, as a safety precaution, a diluted barium sulfate solution may be injected into the nuclear space to check for leakage in the spinal column.

In an embodiment of the eighth feature, the body of material can be inserted into the nuclear space of the spinal disc of the patient using the delivery device according to the invention.

According to a ninth aspect, the present invention is directed to the use of a silicone-based material for the manufacture of a nucleolar replacement device for the treatment of degenerative discs in the human spinal column.

In this aspect, the nucleus nucleus replacement device may have one or more features in accordance with the first aspect of the invention.

In a tenth aspect, the invention is a delivery mechanism for implanting a device according to the first feature in an annulus of an intervertebral disc of a patient. The delivery mechanism,

A delivery mechanism having a first tip for delivering the material body into the ring while the material is in the first state; And dismantling means located at the first end of the delivery mechanism, wherein the dismantling means separates the delivery mechanism from the body of material following delivery to the annulus of the device.

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In one embodiment of the tenth aspect, the dismantling means is a crimping means for releasing the delivery mechanism from the material body when the material has changed to the first state.

In another embodiment of the tenth aspect, the delivery mechanism further comprises a flow restrictor which allows the body of material to easily pass through the delivery mechanism and dismantling means but prevents backflow into the delivery mechanism.

 In yet another embodiment of the tenth aspect, the delivery mechanism further comprises a non load-bearing expandable membrane. The membrane is preferably located adjacent to the dismantling means and may be located around the perimeter of the body of material. The membrane preferably does not penetrate into the body of material and when the body of the material is dismantled from the delivery mechanism by dismantling means the membrane remains around the body of material.

According to an eleventh aspect, the present invention is an intervertebral disc expansion mechanism.

Long transmission member;

And an expandable expansion member.

In the eleventh aspect, the expandable expansion mechanism can be an expandable mechanism by pressurized fluid. The instrument is extended by the fluid to extend the intervertebral disc. The fluid used to extend the instrument is preferably biocompatible. For example, saline, PBS and sterile water are preferable. Alternatively, the instrument may be extended by a settable substance that is movable from the first state to the second state, the solidified material into the instrument while in the relatively low viscosity first state. It is injected and changes to a relatively high viscosity second state after expansion of the instrumentation. More preferably, the expandable expanding member includes a radiopaque marker around the perimeter for searching using radiographic techniques. More preferably, the expandable expanding member is formed of a radiographic material.

In one embodiment of the eleventh feature, the expansion means further comprises an injection portion, the injection portion at least partially extending through the annulus of the intervertebral disc and the fluid entering the instrument through the injection portion.

According to a twelfth aspect, the present invention provides a sealing device for sealing a cavity of a patient's body, wherein the sealing mechanism is:

An enclosed expandable membrane for insertion into the cavity of the body,

The membrane,

Endothelial;

coat; And

Holes, the holes provide a fluid path from the outside of the membrane to the inside of the membrane;

When fluid is injected into the membrane through the aperture, the membrane is at least partially expanded to engage at least a portion of the shell with at least a portion of the inner perimeter of the cavity of the body,

When the hole is sealed so that the fluid remains inside the membrane, the cavity of the body is sealed.

In another embodiment of the twelfth feature, radiographic marking means are included such that the location of the film is monitored using imaging techniques.

In yet another embodiment of the twelfth feature, the fluid can move from a first stage to a second stage, the second stage having a greater viscosity than the first stage.

In the twelfth embodiment, the pores of the membrane are sealed by sealing means, the sealing means being valves, membrane material itself components, ultrasonic welding, temperature welding, ultraviolet curing, sealants. ), It is selected from the group consisting of clipping means and crimping.

Yet another embodiment of the twelfth aspect, the expandable membrane further includes an injection portion through which fluid is injected into the membrane, the injection portion communicating with the aperture. Preferably the infusion is integrally formed with the expandable membrane.

In yet another embodiment of the twelfth aspect, the expandable membrane is compressible so that the sealing mechanism can be inserted into the cavity of the body through an access hole extending from the exterior of the cavity to the interior of the cavity.

Preferably said expandable membrane further comprises an injection portion into which said fluid is injected into said membrane, said injection portion communicating with said aperture.

Preferably the injection portion is formed integrally with the expandable membrane. More preferably, the injection section at least partially extends through the access hole to provide a fluid pathway from the exterior of the cavity of the body to the interior of the membrane.

In another embodiment of this aspect, the cavity of the body is the nucleus space of the intervertebral disc.

According to a thirteenth aspect, the present invention provides a method of sealing a cavity of a patient's body, the sealing method,

Introducing an enclosed inflatable membrane into the cavity of the body;

Expanding the enclosed expandable membrane by injecting fluid into the interior of the membrane through a hole extending from the exterior of the membrane to the interior of the membrane; And

Sealing the membrane such that the fluid remains enclosed within the membrane.

In one embodiment of the thirteenth feature, the fluid can move from a first state to a second state with a viscosity that is relatively greater than the first state.

In another embodiment of the thirteenth aspect, the aperture of the membrane is sealed using a sealing means, the sealing means being a valve, inherent properties of the membrane material, ultrasonic welding, temperature welding, UV light curing. , Sealant, clipping and crimping.

In an embodiment of the thirteenth aspect, the sealing method comprises the use of a sealing mechanism according to the twelfth aspect and the related embodiments.

As will be appreciated by those skilled in the art, various modifications and / or modifications may be made to the invention within the scope of the technical idea. Therefore, embodiments of the present invention are presented to illustrate the present invention, but are not limited thereto.

The invention is applicable as a system for mapping the hollow interior of the patient's body (mapping) and imaged, such as the treatment of the sealing device, the human intervertebral disc for sealing a method of transplanting nucleus pulposus replacement apparatus and the device, the cavity of the patient's body Can be.

Claims (33)

Position display means for being movably inserted in the cavity of the body of the patient and indicating a position thereof by transmitting a signal for the position disposed inside the cavity of the body; Position detecting means for detecting a position of the position display means receiving a signal from the position indication means; And Process means for analyzing a signal of said position indicating means and providing an output signal indicative of the position of said position indicating means relative to said position detecting means. The method of claim 1, wherein the position indication means is a transmitter means, the system of the position detection means is characterized in that the receiver means. The apparatus of claim 1, wherein the position indicating means is reflecting means, the position detecting means is a transceiver means, and the signal is first transmitted from the transceiver means and then by the reflecting means. System, which is reflected by the transceiver means. The system of claim 1, wherein the output signal provided by the process means is used to generate a map of the cavity of the body. 5. The system of claim 4, further comprising a comparison display representing a visual comparison of an actual image of the map and the cavity of the body . 6. The system of claim 5, wherein the actual image is obtained using an imaging technique selected from the group consisting of X-ray imaging technique, magnetic resonance imaging technique, and computer aided tomography. 7. The system of claim 6, wherein the actual image is obtained prior to the mapping of the cavity of the body. 5. The apparatus of claim 4, further comprising tissue ablation means for ablation of tissue in the cavity of the body, wherein the tissue ablation means is movable relative to the position detection means, wherein the position of the position indicating means is in the tissue. And located in close proximity to the position indicating means to indicate the position of the ablation means . 9. The system of claim 8, wherein said tissue ablation means is a radio-frequency ablation device. 9. The system of claim 8, wherein said tissue ablation means is a plasma radiating device. The method of claim 5, The actual image is obtained during mapping of the cavity of the body. 6. The system of claim 5, wherein the actual image is continuously updated during the mapping of the cavity of the body. The system of claim 1, wherein said position detection means can be located outside the cavity of the body. The system of claim 1 wherein said position detection means can be located in a cavity of the body. The method of claim 1, further comprising observation means for imaging the interior of the cavity of the patient's body , The observation means, First imaging means located within a cavity of a patient's body and for generating a first image inside the cavity ; Second imaging means located within the cavity of the body and for producing a second image inside the cavity ; Including , The second imaging means, it characterized in that the system which is located in a position that indicates the number of relatively move and position of said first image a second imaging means relative to the first imaging means. The system of claim 1 wherein the cavity of the body is the nuclear space of the intervertebral disc. The system of claim 1 wherein the cavity of the body is a cavity of a joint . As a method of mapping the interior of the cavity of the patient's body, the mapping method, Inserting a position indicating means into the cavity of the body, which can be arranged at various positions within the cavity of the body; Positioning the position detecting means for receiving a signal from the position indicating means; And Analyzing the signal and providing an output indicative of the relative position of the position indicating means relative to the position detecting means. 19. The method of claim 18, wherein analyzing the signal is performed by processor means. 19. The method of claim 18, wherein said position indicating means is a transmitter means and said position detecting means is a receiver means. 19. The apparatus of claim 18, wherein the position indicating means is a reflector means, the position detecting means is a transceiver means, and the signal is first transmitted from the transceiver means and then again by the receiver means. A method for mapping the interior of a cavity of a patient's body, which is reflected by means. 20. The cavity of a patient's body according to claim 19, further comprising the step of generating a map of the cavity of the body using an output indicating the position of the position indicating means relative to the position detecting means. How to map. 23. The method of claim 22, further comprising displaying on the display means a map of the cavity of the body. 23. The method of claim 22, further comprising comparing the map with an actual image of the cavity of the body. 25. The method of claim 24, wherein the actual image is obtained using an imaging technique selected from the group consisting of X-ray imaging technique, magnetic resonance imaging technique, and computer aided tomography. To map the inside of the cavity of the patient's body. The method of claim 24, wherein comparing the map with an actual image of a cavity of the body, Determining an actual position of the position detecting means with respect to the cavity of the body; And And superimposing the actual position of the position detecting means on the display means together with the actual image of the cavity of the body. 23. The method of claim 22, further comprising updating the map . An apparatus for mapping the inside of a cavity of a patient, wherein the mapping apparatus, A support member that can be partially positioned in the cavity of the body; Position indicating means that can be coupled to the support member, can be located in a variety of within the cavity of the body; Position detecting means for receiving a signal from said position display means; And And processing means for analyzing the signal and providing an output indicating the relative position of the position indicating means relative to the position detecting means. 29. The apparatus of claim 28, wherein said position detecting means can be coupled to said support member and can be located within a cavity of said body. 29. The apparatus of claim 28, wherein said position indicating device is a transmitter means and said position detecting means is a receiver means. 29. The apparatus according to claim 28, wherein the position indicating device is reflector means, the position detecting means is a transceiver means, and the signal is first transmitted from the transceiver means and then again by the reflecting means. Apparatus for mapping the interior of the cavity of the patient's body, which is reflected by the transceiver means. 29. The method of claim 28, further comprising tissue ablation means for ablation of tissue in the cavity of the body, wherein the tissue ablation means is engageable with the support member and is relatively movable relative to the position detection means. A device for mapping the interior of the cavity of a patient's body. 33. The apparatus of claim 32, wherein said tissue resection means is located at a position opposite said locating means.

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